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Vaccine

RSV lot1 Group for Respiratory Syncytial Virus

Phase 3
Waitlist Available
Research Sponsored by GlaxoSmithKline
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
has a negative pregnancy test on the day of study intervention administration,
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from day 1 to day 30 (including day 30)
Awards & highlights

Study Summary

This study is evaluating whether the RSV MAT vaccine is safe and effective when given to healthy non-pregnant women 18-49 years of age.

Eligible Conditions
  • Respiratory Syncytial Virus

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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People who can follow the study's instructions and who the researcher believes will do so.
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The woman did not have a positive pregnancy test on the day of the study intervention.
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This means that there is no condition present that would prevent the injection from being given in both the left and right deltoid muscles.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from day 1 to day 30 (including day 30)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from day 1 to day 30 (including day 30) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Flu D-QIV Haemagglutinin Inhibition (HI) Antibody Titers Against 3 Influenza Strains for Participants in Flu+Placebo Group and RSV+Flu Pooled Group at Day 31
Percentage of Participants Reporting SAEs in RSV Pooled Group, RSV+Flu Pooled Group and Flu+Placebo Group
Percentage of Participants Reporting Serious Adverse Events (SAEs) in RSV Pooled Group, RSV+Flu Pooled Group and Flu+Placebo Group
+4 more
Secondary outcome measures
Flu D-QIV HI Antibody Titers Against 3 Influenza Strains for Participants in Flu+Placebo Group and RSV+Flu Pooled Group at Day 1 and Day 31
RSV A Neutralizing Antibody Titers for Participants in RSV Pooled Group and RSV+Flu Pooled Group at Day 1 and Day 31
RSV A Neutralizing Antibody Titers for Participants in RSV lot1, RSV lot2 and RSV lot3 Groups at Day 1 and Day 31
+6 more

Trial Design

5Treatment groups
Experimental Treatment
Active Control
Group I: RSV+Flu pooled GroupExperimental Treatment1 Intervention
Participants randomized in this group received one dose of RSVPreF3 vaccine (RSV MAT vaccine) from one of the three lots used (Lot 1, Lot 2 or Lot 3 of same formulation of RSVPreF3 vaccine) and one dose of the Flu D-QIV vaccine on Day 1, and were followed up until the end of the study (Day 181). The participants in this group were considered for the immunogenicity and safety analyses of the RSV MAT and Flu D-QIV vaccines.
Group II: RSV lot3 GroupExperimental Treatment1 Intervention
Participants randomized to the RSV lot3 Group received one dose of RSV MAT Lot 3 vaccine intramuscularly at Day 1. Participants were also provided with an option of receiving Flu D-QIV vaccine at Day 31 to allow the participants receive the standard of care.
Group III: RSV lot2 GroupExperimental Treatment1 Intervention
Participants randomized to the RSV lot2 Group received one dose of RSV MAT Lot 2 vaccine intramuscularly at Day 1. Participants were also provided with an option of receiving Flu D-QIV vaccine at Day 31 to allow the participants receive the standard of care.
Group IV: RSV lot1 GroupExperimental Treatment1 Intervention
Participants randomized to the RSV lot1 Group received one dose of RSV MAT Lot 1 vaccine intramuscularly at Day 1. Participants were also provided with an option of receiving Flu D-QIV vaccine at Day 31 to allow the participants receive the standard of care.
Group V: Flu+Placebo GroupActive Control2 Interventions
Participants randomized in this group received one dose of Flu D-QIV vaccine co-administered with one dose of placebo at Day 1, and were followed up until the end of the study (Day 181). This group was considered comparator for immunogenicity and safety analyses for RSV+ Flu Pooled group.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
RSVPreF3(120 μg)
2021
Completed Phase 3
~1590
Flu Quadrivalent influenza vaccine (15 μg HA)
2021
Completed Phase 3
~1590

Find a Location

Who is running the clinical trial?

GlaxoSmithKlineLead Sponsor
4,742 Previous Clinical Trials
8,064,775 Total Patients Enrolled
GSK Clinical TrialsStudy DirectorGlaxoSmithKline
3,593 Previous Clinical Trials
6,141,767 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
Illinois
How old are they?
18 - 65
What site did they apply to?
GSK Investigational Site
What portion of applicants met pre-screening criteria?
Met criteria
~464 spots leftby Mar 2025